Newpathw

A new pathway for the regulation and
governance of health research
January 2011

The Academy of Medical Sciences
The Academy of Medical Sciences promotes advances in medical science and campaigns to ensure
these are converted into healthcare benefits for society. Our Fellows are the UK’s leading medical
scientists from hospitals and general practice, academia, industry and the public service. The
Academy seeks to play a pivotal role in determining the future of medical science in the UK, and
the benefits that society will enjoy in years to come. We champion the UK’s strengths in medical
science, promote careers and capacity building, encourage the implementation of new ideas and
solutions – often through novel partnerships – and help to remove barriers to progress.
ISBN No: 978-1-903401-31-6

A new pathway for the regulation and governance
of health research
January 2011

The Regulation and Governance of Health Research
Acknowledgements and disclaimer
The Academy of Medical Sciences (AMS) is most grateful to Professor Sir Michael Rawlins FMedSci
and to the members of the working group for undertaking this important review. We thank the
Academy’s Council members and staff, study observers, external review group, Dr Catherine
Elliott (Medical Research Council) and all respondents to the consultation for their contributions
and support. The Academy is grateful to the Department of Health’s National Institute for Health
Research for its financial contribution and we warmly thank Cancer Research UK and the Wellcome
Trust, who each seconded a member of staff to the study. The completion of this complex study in
less than a year would not have been possible without the hard work and commitment of the study
secretariat – Dr Robert Frost (AMS), Miss Emma Greenwood (Cancer Research UK), Dr Rachel
Quinn (AMS), and Dr Beth Thompson (Wellcome Trust) – to whom we are immensely grateful.
This report is published by the Academy of Medical Sciences and has been endorsed by its Officers
and Council. Contributions by the working group were made purely in an advisory capacity. The
members of the working group participated in an individual capacity and not as representatives
of, or on behalf of, their affiliated hospitals, universities, organisations or associations. Their
participation should not be taken as endorsement by these bodies.
All web references were accessed in January 2011.
© The Academy of Medical Sciences

3
Contents
Contents
Summary 5
1 Introduction 9
2 Our principles and vision for the regulation and governance pathway 19
3 Culture around health research 23
4 NHS research and development 31
5 Clinical trials of investigational medicinal products 43
6 Use of patient data in health research 57
7 Use of tissue and embryos in research 69
8 Ethics review 73
9 A new Health Research Agency 81
10 A new regulation and governance pathway 93
Recommendations 97
Annex I: The current UK regulatory and governance pathway 103
Annex II: Working group membership 111
Annex III: Review group membership 113
Annex IV: Respondents to the calls for evidence 115
Annex V: Abbreviations and acronyms 121

44

5
SUMMARY
Health research underpins the prevention
and treatment of ill health and brings benefits
across the UK population. It provides patients
with early access to new and innovative
treatments, it improves the quality and
efficiency of health services for the wider public
and it attracts investment and jobs into the UK.
The UK’s first-class universities and hospitals,
vibrant medical science industries, strong
health research charities and unified healthcare
systems have all contributed to our traditional
status as a world leader in health research.
In recent years, steps taken by the National
Institute for Health Research (NIHR) in
England, and similar initiatives in the devolved
nations, have created the infrastructure and
facilities to increase the standing of the NHS as
an academic and commercial research partner.
Yet despite these strengths, there is evidence
that UK health research activities are being
seriously undermined by an overly complex
regulatory and governance environment.
This is evidenced by a fall in the UK’s global
share of patients in clinical trials, and by the
increased time and costs of navigating the UK’s
complex research approval processes. As a
specific example, a recent analysis from Cancer
Research UK showed that after its funding for a
study has been agreed, it now takes an average
of 621 days to recruit the first patient. In short,
the current situation is stifling research and
driving medical science overseas.
In spring 2010 the Academy of Medical
Sciences was invited by Government to review
the regulation and governance of health
research involving human participants, their
tissue or their data. A working group chaired
by Sir Michael Rawlins FMedSci was convened
to undertake the review. The group received
over 300 submissions from across industry,
academia, the NHS, charities and public sector
bodies, as well as from regulators themselves.
There was a broad consensus about the key
problems, and a clear desire from those
consulted to see the position improved.
As researchers strive to develop new and
better treatments, to improve health services
and to tackle the challenges of an aging
population, there is – more than ever – a need
for a regulation and governance pathway that
protects the safety and interests of patients
without introducing unnecessary bureaucracy
or complexity. The Academy therefore
welcomed the Government’s support for health
research in the 2010 Health White Paper and
its commitment to ‘consider the bureaucracy
affecting research…and bring forward plans for
radical simplification in light of the Academy’s
review’. The recommendations in this report
are intended to deliver a level of change that
will substantially improve the regulation and
governance pathway – as well as the culture
within which it operates – for the good of
patients, the public and the economy.
Regulation should safeguard
patients and facilitate research
Patients, the public and researchers have a
common interest in ensuring that research is
conducted safely and effectively. In this report,
we argue that the application of regulation
should be both proportionate and symmetrical.
A ‘one-size-fits-all’ approach to regulation
damages us all. Instead, regulation of health
research should be proportionate to the risks
and benefits to individuals and society. Those
involved with regulation and governance
must recognise that the current approach is
asymmetrical; approving an inappropriate
study is clearly unacceptable, but delaying
or prohibiting an appropriate study harms
future patients as well as society as a whole.
We propose that the UK’s regulation and
governance framework around health research
should be underpinned by the following four
principles:
Summary

66
1. To safeguard the well-being of research
participants.
2. To facilitate high-quality health research to
the public benefit.
3. To be proportionate, efficient and
coordinated.
4. To maintain and build confidence in the
conduct and value of health research
through independence, transparency,
accountability and consistency.
A complex and bureaucratic
regulatory environment is stifling
health research in the UK
The existing regulation and governance
pathway has evolved in a piecemeal manner
over several years. New regulatory bodies
and checks have been introduced with good
intentions, but the sum effect is a fragmented
process characterised by multiple layers of
bureaucracy, uncertainty in the interpretation
of individual legislation and guidance, a lack of
trust within the system, and duplication and
overlap in responsibilities. Most importantly,
there is no evidence that these measures have
enhanced the safety and well-being of either
patients or the public.
Despite recent attempts to improve individual
parts of the regulation pathway, significant
challenges remain:
Delays and duplication in obtaining
research permissions from NHS Trusts.
The current process for obtaining research
permissions across multiple NHS sites is
inefficient and inconsistent, characterised by
NHS Trusts reinterpreting assessments already
undertaken by regulators such as the National
Research Ethics Service and duplicating checks
that could be done once across a study. Local
negotiation of research contracts and costings
are a further source of delay. Together with
the lack of agreed timelines within which
approval decisions are made, the governance
arrangements within NHS Trusts are the single
greatest barrier to health research.
Complexity and inconsistency across the
regulation pathway.
Researchers must navigate numerous approval
and permissions processes, coordinated by
multiple bodies with overlapping responsibilities.
Further complexity is added by different
legislative and regulatory arrangements across
the devolved nations. Approval processes
are often undertaken in series, rather than
in parallel, and conflicting advice by different
bodies leads to inconsistency, confusion and
variable standards.
A lack of proportionality in the regulation of
clinical trials.
The broad scope and ‘one-size-fits-all’ approach
of the EU Clinical Trials Directive (CTD) places
an unnecessary regulatory burden on clinical
trials of both new products and established
drugs. The Medicines and Healthcare products
Regulatory Agency (MHRA) provides timely
authorisation of clinical trials but there are
concerns about its interpretation of the EU
Directive, the lack of consistent advice to
investigators and sponsors, and the approach
taken during some clinical trial site inspections.
In combination, this situation is hampering
clinical trials and discouraging academic and
commercial health research sponsors from
conducting their studies in the UK.
Inappropriate constraints on access to
patient data.
Patient information is used extensively within
the NHS to underpin all aspects of service
delivery, and is routinely shared in a secure and
confidential manner with members of clinical
care teams. Access to patient data is vital for
many important research uses, for example
to identify causes of disease, to determine
the long term effects of treatment and to
show how public health can be improved, for
example, by the better provision of services.
However, access to patient data for research
is currently hampered by a fragmented legal
framework, inconsistency in interpretation of
the regulations, variable guidance and a lack of
clarity among investigators, regulators, patients
and the public.

7
SUMMARY
A healthcare culture that fails to fully
support the value and benefits of health
research.
The Academy has long argued for a step change
in the culture and attitude of the NHS towards
research. Although some NHS Trusts recognise
the importance of research as the bedrock of
effective and evidence-based healthcare, NHS
managers have traditionally been under intense
pressures to deliver immediate healthcare
targets. There are few equivalent incentives to
encourage support from NHS staff for health
research. Together with their concerns about the
obligations of an overly complex regulation and
governance pathway, this can cause NHS Trusts to
give research a low priority. As a result, the NHS
is still perceived as a difficult and unpredictable
place in which to conduct clinical studies.
Clearing the path: streamlining the
regulation and governance pathway
In this summary we present only the
major recommendations that address the
problems identified during our review. Further
recommendations can be found in the relevant
sections of the report. We recommend the
following:
Creating a new Health Research Agency to
rationalise the regulation and governance
of all health research.
The Agency should have two major functions:
A National Research Governance Service
that would:
• Eliminate inefficiency and support NHS
Trusts and researchers by undertaking
all NHS research governance checks just
once. This will ensure common standards
and a consistent interpretation of the
requirements.
• Oversee new arrangements that enable
Trusts to determine local research
feasibility within agreed timelines.
• Allow Trusts to focus on monitoring local
capacity, conduct and performance.
A single system for ethical approvals.
This system would encompass the
responsibilities for both general ethical approval
(the National Research Ethics Service), as well
as specialist approvals and licenses (for studies
involving patient data, human tissue, gene
therapy or human stem cells etc.). Bringing
together the regulatory functions that are
currently fragmented across multiple bodies will:
• Provide clarity on the interpretation of
legislation, develop best practice, remove
inefficiencies by pooling resources, and
reduce timescales.
• Establish a single point of contact and
source of advice to support investigators
and sponsors.
• Ensure transparency and accountability to
healthcare professionals, patients and the
wider public.
The new Health Research Agency (HRA) should
work alongside systems in the devolved nations
to create an efficient, seamless approach. Its
success in simplifying research governance and
approval processes should be formally reviewed
on a periodic basis.
Improving the UK environment for
clinical trials.
To address the challenges identified around
clinical trials, improvements need to be made
at both the European and UK levels. The
Department of Health and Department for
Business, Innovation and Skills – supported by
the MHRA and other UK stakeholders – should
seek to ensure that the CDT is revised to:
• Reduce the scope of the Directive.
• Ensure that approval and monitoring
requirements are proportionate to risk.
• Simplify the requirements for safety
reporting to improve the quality of drug
safety data and monitoring.
The relationship between the new HRA and
MHRA will be crucial in improving the current
system and should be enshrined in a duty of
consultation between the two organisations. The
HRA and MHRA should work in consultation to:

88
• Ensure a more proportionate approach to
clinical trials regulation.
• Provide consistent and clear guidance on
the interpretation of the scope of the EU
Clinical Trials Directive.
• Improve the approach and process of
Good Clinical Practice (GCP) monitoring
inspections so that they form a
proportionate and constructive part of the
regulatory process.
Providing access to patient data that
protects individual interests and allows
approved research to proceed effectively.
We urge the Government to evaluate progress
in implementing the recommendations of the
2008 Data Sharing Review. Specifically, we
recommend that:
• ‘Safe havens’ are established as a matter
of urgency to allow access to data for
approved research.
• Accredited investigators and research team
members should be considered part of a
clinical care team to enable them to identify
patients eligible for approved studies.
• The UK Data Protection Act should be
reviewed to identify and amend aspects
requiring clarification and to inform
proposed revisions to the EU Data Directive.
Embedding a culture that values research
within the NHS.
To support improvements to the regulation and
governance environment, a cultural change
is required within the NHS to embed health
research as a core function, to foster a more
facilitative approach to research governance
and to promote public and patient engagement
in research. We recommend that:
• The core role of health research in the
delivery and improvement of the NHS
should be more widely communicated to
healthcare staff at all levels.
• Heath research should be formally and
irreversibly embedded into NHS leadership
and governance processes by the following:
the use of appropriate metrics and
incentives; training the NHS workforce
to ensure it can support health research;
and ensuring that within each Trust there
is an executive director with specific
responsibilities to promote health research.
Guide to the report
• In Chapter 1 we provide a brief introduction to the opportunities for UK health research
and the challenges presented by the current regulation and governance pathway.
A guide to the existing regulation pathway is provided in Annex I.
• In Chapter 2 we set out the principles on which we believe the regulation and governance
pathway should be based. These principles form the basis for the discussion, conclusions
and recommendations that follow in the later chapters.
• In Chapter 3 we outline the importance of a supportive culture and attitude towards
research on the part of patients and the public, the NHS and other stakeholders.
• Chapter 4 deals with the issue of NHS RD approvals and includes discussion of a
proposed National Research Governance Service. This is also revisited in Chapter 9.
• Specific issues relating to clinical trials, use of patient data in research, use of human
tissue and research ethics, are discussed in Chapters 5, 6, 7 and 8 respectively. Each
of these chapters contains specific conclusions and recommendations related to those
areas, and Chapter 9 considers how they might be dealt with by a proposed new Health
Research Agency.
• The overall conclusions of the report and a description of our proposed new regulation
and governance pathway are set out in Chapter 10.

9
1 INTRODUCTION
1 Association of the British Pharmaceutical Industry (2010). The pharmaceutical industry’s contribution to the UK economy and beyond.
http://www.abpi.org.uk/pdfs/The%20Pharmaceutical%20Industrys%20Contribution%20to%20the%20UK%20Economy%20and%20Beyond.pdf
2 For further information see http://www.acmedsci.ac.uk/p118pressid63.html
3 Department for Business, Innovation and Skills (2009). International comparative performance of the UK research base. http://www.bis.gov.
uk/assets/biscore/corporate/migratedd/publications/i/icpruk09v1_4.pdf
4 Academy of Medical Sciences (2010). Reaping the rewards: a vision for UK medical science. http://www.acmedsci.ac.uk/download.php?file=/
images/publicationDownload/Reapingt.pdf
1.1 Overview
Health research provides the knowledge that
underpins improvements in healthcare and
allows people to live longer and healthier lives.
By improving our understanding of medical
conditions, and by developing new ways to treat
and prevent disease, health research brings
great benefit to individuals, their families and
society. Throughout this report we demonstrate
the health and economic benefits of undertaking
this research in the UK. For example:
• Patients gain early access to innovative
medicines, devices, procedures or
diagnostic techniques.
• Healthcare professionals gain early
experience and expertise in the selection
and use of new therapeutic interventions.
• Evidence to support public health
interventions is relevant and available
quickly to healthcare professionals and
policymakers.
• Commercial health research brings
substantial economic and social benefits,
for example, the UK’s pharmaceutical sector
is estimated to invest approximately £11.8
million per day in research and development
(RD), more than any other industrial
sector, and employs over 72,000 people.1
Health research relies on the involvement of the
public, patients and healthy volunteers (section
1.4). Regulation and governance mechanisms
are in place to safeguard research participants
from the potential risks of research, while also
ensuring that high quality research can take
place for public benefit. The regulation and
governance pathway needs to manage these
risks and benefits in a proportionate manner.
As the population ages and the NHS attempts
to improve quality and efficiency, the need
for a fertile health research environment has
never been more important. It is essential
to have a regulatory system that facilitates
research without unnecessary bureaucracy or
complexity. There are concerns that public and
private investment, the UK’s research assets,
and the strong public support for research are
failing to be maximised because of the stifling
regulatory and governance environment. The
threat to the UK’s traditional position at the
forefront of health research is evidenced by
a fall in the UK’s global share of patients in
clinical trials and the increasing cost and time
taken to get research approved (section 1.2).
In spring 2010, the Department of Health for
England commissioned the Academy of Medical
Sciences to conduct a review of the regulatory
and governance environment for health research
in the UK, with a particular focus on clinical
trials (section 1.3).2 Professor Sir Michael
Rawlins FMedSci chaired the Academy working
group established to undertake this review. The
recommendations made to reduce and streamline
the regulatory burden — without undermining
effectiveness — have been informed by evidence
from over 300 individuals and organisations
across the health research community.
1.2 Regulation and governance
1.2.1 Health research: a UK strength
The UK has traditionally been a world leader in
research to understand and treat disease. Our
scientific publications produce over 12% of the
world’s citations in both the clinical and health
sciences and we have created nearly a quarter
of the world’s top 100 medicines (for example,
see Box 1.1).3,4 The UK’s success has been due
to our superior academic health research base,
our coordinated landscape of private, public
and charity funders, the NHS and the support of
the public for research (Box 1.2).
1 Introduction

1010
Box 1.1 Monoclonal antibodies
Research supported by the UK Medical Research Council in the 1970s and 1980s led to the development
of monoclonal antibodies and, in particular, to humanised versions of these antibodies that are suitable for
therapeutic use. Antibody therapies now constitute a third of all new drugs for a variety of major diseases,
including cancer and arthritis, and the market is forecast to grow to over $43 billion by 2012.5 Adalimumab
(Humira®) is one example of an antibody therapy that is now used to treat various inflammation diseases
such as adult and juvenile rheumatoid arthritis, psoriatic arthritis and Crohn’s disease. By August 2009,
Humira was being used by 370,000 patients in 80 countries and it is estimated to become one of the world’s
top earning pharmaceutical products with sales reaching $10 billion by 2016.6
Box 1.2 Health research: a UK strength
The ability of the UK to continue to deliver health benefits to the public, patients and society
requires us to maximise the opportunities available from the following:
• The National Health Service (NHS). Almost all health research involving human participants
is undertaken in NHS hospitals and GP practices. An NHS culture that is supportive of
research is therefore vital. The NHS treats the largest group of people within a single
healthcare system anywhere in the world, and keeps detailed records on all patients from
birth to death. Access to, and analysis of, these data is essential in epidemiological research
to improve the safety of medicines, to identify potential participants for clinical trials and to
identify those who would benefit most from targeted health interventions.
• Our world-class universities and researchers. Four of the UK’s universities are in the top six
in the world.7 The UK has produced 30 Nobel Prize winners in biomedical research.8 Recent
initiatives such as the Biomedical Research Centres and Units and Academic Health Science
Centres have strengthened links between academia and the NHS.9
• A vibrant research-intensive life sciences industry. Pharmaceutical and biotechnology
companies, manufacturers of medical devices and diagnostics, and contract research
organisations are an important part of the UK’s knowledge economy. They are attracted by
the availability of skilled researchers and the NHS. Commercial, academic and charity funded
studies often share the same infrastructure and can complement and support
each other.
• Thriving health research charities (e.g. Wellcome Trust, Cancer Research UK, British
Heart Foundation and Arthritis Research UK). Each year, medical research charities invest
£1.1billion in UK health research and facilitate the involvement of patients in research.10
• Sustained public funding from the MRC and the Department of Health’s National Institute
for Health Research (NIHR). Both funders support essential infrastructure for health research,
as well as funding individual programmes and projects. In October 2010 the Government
announced that public funding for health research would increase over the next four years.
• Patients and the public who are supportive of research both as research participants and as
contributors to health research charities.
5 Datamonitor (2007). Monoclonal antibodies report part II: Companies – holding mAbs in portfolio promises protection against the looming
2011-12 patent cliff. Datamonitor, London.
6 EvaluatePharma (2010). Humira set to steal Avastin’s crown. http://www.evaluatepharma.com/Universal/View.aspx?type=Storyid=211976
isEPVantage=yes
7 Times Higher Education (2009). Top 200 universities. http://www.timeshighereducation.co.uk/hybrid.asp?typeCode=438
8 For further information see http://www.mrc.ac.uk/Achievementsimpact/NobelPrize/index.htm
9 H M Government (2010). Life Sciences 2010: delivering the blueprint. http://www.bis.gov.uk/ols
10 Association of Medical Research Charities (2010). Challenge for Government. http://www.amrc.org.uk/challenge

11
1.2.2 Regulation and governance: a UK
weakness?
In the past ten years the UK’s position in health
research has been under threat and our global
share of research activity has fallen. Trends
causing concern include the following:
• In 2002, 46% of EU products in clinical
trials were being developed in the UK; by
2007 this had fallen to 24%.11
• While data from the MHRA show that the
number of trials approved has stayed
constant between 2004 and 2008, our
global market share of patients in trials has
dropped from 6% to 2-3%.12
• Almost half of the representatives
of major pharmaceutical industries
surveyed in 2008 indicated that they
expected to reduce the number of clinical
trials in the UK.13
• Commercial and non-commercial
researchers have indicated that the
complexity of the regulation and
governance pathway is limiting
the amount of research they do.14
Throughout the course of our review, we found
evidence that the regulatory and governance
environment has led to delays, increased cost and
created unnecessary barriers to the recruitment of
patients.15,16 For example, a recent analysis from
Cancer Research UK showed that after its funding
for a study has been agreed, it now takes an
average of 621 days to recruit the first patient.17
Most importantly, there is a consensus that these
regulatory and governance measures have not –
either individually or collectively – enhanced the
safety or well-being of either patients or
the public.
A survey of UK Life Sciences Leaders in July
2010 identified the regulatory burden as
one of four key areas that the new Coalition
Government should address.18 Also in July, the
Department of Health’s White Paper ‘Equity
and excellence: Liberating the NHS’ was
published.19 This paper committed to ‘consider
the legislation affecting medical research, and
the bureaucracy that flows from it, and bring
forward plans for radical simplification’ in light
of the Academy’s review.
1.2.3 The current regulation and
governance pathway
The complexity of the current regulatory and
governance process is outlined in Annex I and
illustrated in Figure 1.1.
In the past five years several attempts have
been made to improve the UK’s regulation
and governance pathway. These initiatives
are outlined throughout this report and
include programmes by the National Institute
for Health Research (NIHR) to create the
infrastructure and facilities to improve the NHS
research environment, and efforts by regulators
to reduce timelines for clinical trials and ethical
approval. In this report we have sought to
build on these individual improvements while
taking a view of the regulation and governance
pathway in its entirety.
1.3 The Academy’s review of
regulation and governance
In January 2010 the Academy published ‘Reaping
the rewards: a vision for UK medical science’,
1 INTRODUCTION
11 Bioscience Innovation Growth Team (2009). Review and refresh of bioscience 2015. http://www.berr.gov.uk/files/file49805.pdf
12 Kinapse (2008). Commercial clinical research in the UK: report for the Ministerial Industry Strategy Group Clinical Research Working Group.
http://www.ukcrc.org/index.aspx?o=2873
13 Association of the British Pharmaceutical Industry (2008). Bellwether Industry’s Confidence In UK Slumps – ABPI/CBI Survey.
http://www.abpi.org.uk/press/press_releases_08/200308.asp
14 OnCoreUK (2009). The effect of regulation and governance on research led by pathologists or involving pathology in the UK.
http://www.oncoreuk.org/documents/EffectofRegulationandGovernanceSurveyReport-onCoreUK2009-09-07o.pdf
15 Hackshaw A, et al. (2008). Setting up non-commercial clinical trials takes too long in the UK; findings from a prospective study. Journal of the
Royal Society of Medicine 101, 299-304.
16 Both CR-UK and UCL indicated large increase in the number of staff required since 2003/04 to deal with the administration of Clinical Trial
Applications, trial coordination and monitoring, pharmacovigilance (PV) tasks and quality assurance. These staffing increases provide a simple
indication of the escalating resources and infrastructure required.
17 The 621 days is the time from decision to support the study to first patient entered at the first site. This is the average time from 25 studies
approved by Cancer Research UK’s Clinical Trials Awards and Advisory Committee during the period of November 2006 to July 2007.
18 Science, Technology Innovation Partners (2010). Life science leaders’ survey. http://www.standipartners.com/download/2010-UK-Life-
Science-Leaders-Survey-Full-Report.pdf
19 Department of Health (2010). Equity and excellence: liberating the NHS. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/
PublicationsPolicyAndGuidance/DH_117353

1212
which set out the challenges for an incoming
Government.20 The report proposed that a more
fertile research environment could be created,
at less cost, by streamlining and improving
current regulation, and recommended that this
be informed by an independent review of the
existing governance framework. In response,
the Department of Health commissioned the
Academy to conduct this review.
1.3.1 Terms of reference
The study was launched in May 2010 with the
following terms of reference:
• To review the regulatory and governance
environment for health research in the UK,
with a particular focus on clinical trials.
• To identify key problems and their
causes, including unnecessary process
steps, delays, barriers, costs, complexity,
reporting requirements and data collection.
• To make recommendations with respect
to the regulation and governance pathway
that will achieve the following: increase
the speed of decision-making; reduce
complexity; and eliminate unnecessary
bureaucracy and cost. In making
recommendations for change, the need
to ensure the protection of the safety
of participants, as well as the need for
appropriate arrangements for governance
and accountability, have been central.
During the course of the Academy’s review,
the Department of Health set out proposals to
reorganise ‘arm’s-length bodies, including the
suggestion that a single regulator of research
should be established.21 The Academy was
asked to consider the possible scope and
function of this new body in the context of this
review (see Chapter 9).
Figure 1.1: The current regulation and governance pathway
20 Academy of Medical Sciences (2010). Reaping the rewards: a vision for UK medical science. http://www.acmedsci.ac.uk/download.php?file=/
images/publicationDownload/Reapingt.pdf
21 Department of Health (2010). Liberating the NHS: report of the arm’s-length bodies review. http://www.dh.gov.uk/en/
Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_117691
National Research Ethics Service
UK-wide single ethics opinion
Specialist ethics review
e.g. Gene Therapy Advisory Committee
Access to patient data
e.g. Caldicott guardian and Ethics and Confidentiality Committee
Human Tissue Authority
Site licence for tissue storage (England, Wales and
Northern Ireland only)
Human Fertilisation and Embryology Authority
Project licence for embryo research
Administration of Radioactive Substances
Advisory Committee
Ministry of Justice
For research in the criminal justice system
Medicines and Healthcare products Regulatory Agency
Clinical Trial Authorisation
NHS RD Permissions
Administered by each NHS Trust where research will take place
Protocol
amendments
Safety
reporting
Monitoring
Inspection
Assessments
Ongoing
requirements
Approvals Authorisation Permissions
Integrated
Research
Application
System
Study
starts

13
1 INTRODUCTION
1.3.2 Geographical scope
England, Scotland, Wales and Northern
Ireland have separate healthcare systems
with different administrative arrangements.
Although this review was commissioned by
the Department of Health in England we have
tried, in so far as it has been possible, to take a
UK-wide approach. Stakeholders made it clear
that the system for permissions, approvals
and authorisations in the NHS must be joined
up across the UK. A coordinated UK approach
will become even more important in the face
of growing competition from other nations who
are investing in, and enhancing, their health
research capacity.
1.3.3 Conduct of the study
Professor Sir Michael Rawlins FMedSci chaired
the Academy working group established to
undertake this review, which included health
researchers and clinicians from academia,
industry, the NHS, and the charity sector,
experts in bioethics and law, a representative of
a patient charity, and a lay member. Observers
from the MHRA, the Department of Health
and the Department of Business Innovation
and Skills also joined the initial working group
meetings to clarify factual points but were not
present for the discussion of the conclusions
and recommendations of the study. A list of
working group members and observers can be
found in Annex II.
Two calls for evidence were issued to inform
the review:
• The project was launched with an initial call
for evidence in May 2010 to determine the
priorities for the study.
• A second call for evidence was launched
in July 2010 to seek responses to the
Department of Health’s announcement that
it was considering the creation of a new
arm’s-length body to regulate research.
In addition to considering the written responses
to the calls for evidence, the working group
held evidence sessions with Wendy Fisher
(NHS RD FORUM), Sir Nick Partridge (Chair of
INVOLVE and Chief Executive of the Terrence
Higgins Trust), Mr Marc Taylor (Department of
Health) and Professor Kent Woods FMedSci,
(Chief Executive, MHRA).
The Chair and individual working group
members also had discussions with other
stakeholders, including many of the regulatory
bodies and with representatives from the
devolved administrations, at various stages
of the project. The Association of British
Pharmaceutical Industry (ABPI) and the
Bioindustry Association (BIA) organised a
meeting to discuss key issues for industry and
working group members and the secretariat
spoke to the UK Clinical Research Collaboration
(UKCRC) Board and its Regulation
Governance sub-group.
The Academy also supported the Association
of Medical Research Charities and INVOLVE in
organising a Patient and Public Involvement
(PPI) workshop for patients and their
representatives interested in health research.
The workshop provided an opportunity for
participants to discuss their hopes and concerns
around regulation and governance.22
We thank all those who contributed to this
study, including all those who submitted
evidence (Annex IV). We are very grateful to
Cancer Research UK and the Wellcome Trust
for each seconding a member of their staff
to the study on a part-time basis and to the
NIHR for making a contribution towards the
costs of the study. The report was reviewed by
a group appointed by the Academy’s Council
(Annex III) and it has been approved by the
Academy’s Council.
1.4 What do we mean by health
research?
This report focuses on the regulation and
governance of research involving human
22 Association of Medical Research Charities INVOLVE (2010). Patient perspectives on the regulation and governance of medical research.
http://www.invo.org.uk/pdfs/AMRCINVOLVERegulationWorkshopReport211210.pdf

1414
participants, their tissue or their data. We
use the term health research but the terms
‘clinical research’ and ‘medical research’ are
also commonly used. Health research has many
aims, including:
• To understand the biology of disease and
prevent ill health.
• To find new ways to treat disease and
improve the quality of life for people living
with ill health.
• To develop new diagnostic and therapeutic
interventions (for example new medicines,
devices, or surgical techniques).
• To monitor the efficacy and safety of
interventions once they are in use.
Our review focuses on approaches to
health research that are broadly labelled
as ‘experimental medicine’, ‘clinical trials’,
and ‘epidemiology’, and that involve human
participants, their tissues or their data. The
regulation and governance of research involving
animals is outside the scope of this report.
1.4.1 The involvement of patients and
healthy volunteers
Much health research relies on the involvement
of patients and healthy volunteers usually in a
hospital or other healthcare setting. Without
the participation of patients and volunteers – or
access to their tissue and/or data samples – the
research that led to the advances described
in this report would not have been possible.
The UK has a long history of public support
for health research, as evidenced by the large
number of participants in clinical trials and
population studies (e.g. UK Biobank) and the
generous contributions to medical research
charities such as Cancer Research UK and the
British Heart Foundation. Personal involvement
in research studies can bring direct benefits
to participants themselves, who experience
enhanced care and monitoring, play a more
active role in their healthcare and often gain
earlier access to new medicines.
As well as the many benefits of health
research, there are risks. For most health
research studies these risks are minimal.
However, for some studies there may be
potential consequences to participants such
as extended hospital stays, the possibility of
the experimental treatment being ineffective,
or risk to physical well-being due to adverse
effects. For studies involving patient data, the
potential risk may relate to security of personal
information. There are also other potential
issues that impact on the decisions of those
organising, hosting or delivering research
(often healthcare providers). For example,
risks to the quality of the study data and the
perceived risk of legal action due to negligent
or non-negligent harm. Alongside the potential
benefits of research, it is these risks that a
regulation and governance pathway should
manage in a proportionate manner.
1.4.2. Experimental medicine
Experimental medicine is a broad term, with
varying definitions. It is most often used to
describe research that aims to identify the
mechanisms (pathophysiology) of disease. This
23 Greenfield JR, et al. (2009). Modulation of blood pressure by central melanocortinergic pathways. New England Journal of Medicine 360, 44-52.
Box 1.3 Experimental medicine: understanding obesity
Obesity has been categorised as an epidemic by the World Health Organization and is often associated
with high blood pressure. A Medical Research Council funded team from the University of Cambridge has
increased our understanding of the underlying disease mechanisms. Their work has included revealing
that the melanocortin 4 receptor (MC4R) gene, which works in the brain to control body weight, is a key
link between the body’s systems for controlling weight and blood pressure.23 MC4R deficiency is the most
common form of inherited human obesity. Together with Lilly Inc in the USA, the team demonstrated that a
new drug that increases the action of MC4R causes an increase in blood pressure in overweight individuals.

15
1 INTRODUCTION
24 Atkin W, et al. (2010). Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial.
Lancet 375 (9726), 1624 – 1633.
25 For further information see http://www.screening.nhs.uk/cms.php?folder=3014
might include determining the genes linked
with susceptibility to a given disease (which
can indicate a potential therapeutic target) or
using an existing drug to better understand
underlying disease mechanisms (see Box 1.3).
It can generate new hypotheses that can be
explored in the laboratory. The term is also
used to describe work done to demonstrate
proof-of-concept evidence of the validity and
importance of new discoveries or of treatments
in development. Experimental medicine can
overlap with Phase I clinical trials (see below).
1.4.3 Clinical trials
Clinical trials are research studies designed to
assess the safety and efficacy of therapeutic
interventions. Such interventions can include
drug treatments, vaccines, devices, screening
(see Box 1.4), surgical procedures, approaches
to disease prevention and improving public
health, radiotherapy, physical and psychological
therapies, educational programmes or methods
of diagnosis. Much of the focus of this report
is on Clinical Trials of Investigational Medicinal
Products (CTIMPs), which involve studying a
drug in humans, often with an emphasis on
new or relatively new drugs (although studies
defined as CTIMPs can vary, as discussed in
Chapter 5).
Trials of new medicines provide important
information not only about their effectiveness
but also how quickly they are absorbed, how
often they need to be taken, and the nature and
frequency of any adverse side effects. Before
it reaches the market, safety and efficacy of a
new medicine must be demonstrated through
a series of stages that are often defined as
follows:
• Phase I studies are about determining
how the body metabolises and responds to
the drug and how it will tolerate increasing
doses. These usually involve small numbers
of healthy volunteers.
• Phase II studies involve small groups of
patients to test whether the drug works for
the disease for which it has been developed
and determine the most appropriate dose.
• Phase III studies involve larger groups of
patients (1,000-5,000) to determine if the
Box 1.4 Ten thousand people each year will avoid bowel cancer through screening
About 1 in 20 people in the UK will develop bowel cancer during their lifetime. In the UK it causes
over 16,000 deaths a year, making it the second biggest cause of death by cancer. In 2010, a 16-year
study funded by Cancer Research UK, the Medical Research Council and the National Institute for
Health Research was completed, which demonstrated that bowel cancer can be prevented with a
simple, once-in-a-lifetime, five-minute screening test.24 The test uses a flexible tube (named the
Flexi-Scope) to examine the lower bowel for the presence of polyps, which are then burnt or snipped
off. Polyps occur in around one in five people over 55, and in 1 in 20 people they develop into cancer.
The study revealed that 10,000 people each year will avoid bowel cancer as a result of incorporating
the Flexi-Scope test into the national bowel screening programme. The study also suggests that
deaths from the disease will drop by almost half (43%) among those who attend screening, saving up
to 3,000 lives a year.
In addition to saving lives, the screening programme could also reduce the costs associated with
treating people with bowel cancer. Research commissioned by the Department of Health suggested
that if a screening programme based on this test was effective this could save an average of £28 for
every person screened. In October 2010 the Government confirmed that Flexi-Scope would be rolled
out nationwide over the next four years.25

1616
Box 1.5 Halting ineffective treatments: surgical stockings
In small trials of patients undergoing surgery, graduated compression stockings had been
shown to reduce the risk of deep vein thrombosis (DVT). National stroke guidelines had
extrapolated from these trials and recommend their use in patients with stroke - despite only
a small amount of evidence. Research led by the University of Edinburgh, published in 2009,
showed that thigh-length graduated compression stockings are not effective at preventing
venous thromboembolism in patients with stroke. As a result, clinical guidelines published in the
UK and internationally were changed and it is estimated that the NHS may save £7 million and
320,000 hours of nursing time a year by cutting the use of stockings for approximately 80,000
people with stroke.28 This study involved patients in hospitals across the world. It was funded
by the Medical Research Council, the Chief Scientist Office of the Scottish Government and the
medical charity Chest Heart and Stroke Scotland.
medicine is both safe and effective.
• Phase IV trials or post-marketing studies
are used to learn more about the drug and
its long term benefits and risks.
The later phases are usually undertaken across
many sites, often in more than one country and
involving larger numbers of patients. The cost
and complexity therefore increases as a new
drug progresses through these phases. Drug
development is a very expensive business –
some estimates put the total cost of bringing a
single new medicine to market at between $0.5
and $1.4 billion.26
Some studies do not focus on the development
of a new drug, but on alternative uses of an
existing drug. Such studies will generally have a
lower associated risk than trials of a completely
new drug. Trials may also focus on determining
whether well-established treatments are
effective and safe (e.g. Box 1.5). Trials of non-
drug interventions will follow different stages
from those listed above.27
1.4.4. Epidemiological research
Epidemiological research aims to understand
factors associated with disease. It includes
investigating events such as causes of death,
the adverse consequences of certain behaviours
such as smoking (Box 1.6), reactions to
preventative regimes, or the provision and
use of health services. Studies in this broad
discipline range from examining the possible
causes and prevention of infectious (e.g. HIV/
AIDs) and non-infectious (e.g. cancer) diseases
to examining poisoning caused by environmental
agents. Epidemiological studies use data on
health, lifestyle, environment and genotype.
They include methods such as the following:
• Cohort studies that follow a defined
population to investigate disease outcomes.
For example the Million Women Study29
involves more than one million UK women
aged 50 and over has been used to study
aspects of women’s health such as the link
between hormone replacement therapy and
various cancers (Box 6.2).
• Case-control studies to compare possible
causal factors in individuals with and
without a specified condition. This involves
collecting data from case and control groups
at a particular point in time. One of the best
known case-control studies is the long-
term programme of research into the link
between smoking and cancer (Box 1.6).
• Ecological studies, which, rather than
examining associations at an individual
level, compare aggregated population
groups. For example, researchers might
analyse hospital admissions for respiratory
conditions by comparing severe asthma
attacks with the local air quality to examine
links between specific pollutants and impact
on human health.
26 Adams CP, Brantner VV (2010). Spending on new drug development. Journal of Health Economics 19, 130–141.
27 Medical Research Council (2008). Developing and evaluating complex interventions: new guidance.
http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILEdID=15585dDocName=MRC004871allowInterrupt=1
28 The CLOTS Trials Collaboration (2009). Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein
thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. The Lancet 373(9679), 1958-1965.
29 For further information see http://millionwomenstudy.org/

17
1 INTRODUCTION
30 MRC (2010). Impact of MRC research. http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC007392
31 Doll R Hill AB (1950). Smoking and carcinoma of the lung; preliminary report. BMJ 2(4682), 739-748.
32 Doll R Hill AB (1954). The mortality of doctors in relation to their smoking habits: a preliminary report. BMJ 228 (i), 1451-1455.
33 Doll R Hill AB(1956). Lung cancer and other causes of death in relation to smoking; a second report on the mortality of British doctors. BMJ
2, 1071.
34 Pell J, et al. (2008). Smoke-free legislation and hospitalizations for acute coronary syndrome. The New England Journal of Medicine 359, 482-
91.
Box 1.6 Reducing smoking-related deaths
Research funded by the MRC, Cancer Research UK and the British Heart Foundation since the 1950s has
shown that people who smoke have lower life expectancy, that passive smoking is harmful and that stopping
smoking can reduce the risk of lower life expectancy.30
In 1950, Doll and Hill published the results of a case-control study31 showing an excess of smokers amongst
patients with lung cancer compared with patients with other diagnoses. They confirmed these findings
in a prospective cohort study of British doctors.32 These individuals have been tracked ever since to see
what illnesses they died of. Among the first results was that the death rate from lung cancer among heavy
smokers was 20 times the rate in non-smokers.33
Over the next half-century, researchers collected more data and the extensive dangers of smoking gradually
emerged. This research has resulted in national public health campaigns and a dramatic reduction over the
past 50 years in the number of smokers. It has also led to bans on smoking in workplaces and public places
after sustained exposure to passive smoking was shown to be harmful. A year after the ban in Scotland
was introduced there was a 17% fall in admissions for heart attacks compared with annual reduction in
admissions for heart attacks of 3% per year in the decade before the ban.34

1818
35 Hampton P (2005). Reducing administrative burdens: effective inspection and enforcement. HM Treasury, London.
36 For further information see http://www.bis.gov.uk/bre

19
2 Our principles and vision for the regulation and governance pathway
2.1 Introduction
Regulation and governance need to promote
high-quality research but also to maintain
public and professional trust in an area that
relates directly to individual safety and dignity.
The various checks and assessments in place
need to safeguard research participants
and the public from potential risks, while
recognising that reliable and valid research
evidence is needed to provide effective
medical interventions. An overly complex
and burdensome regulation and governance
pathway does not, in itself, necessarily protect
participants from potential risks or facilitate
research. Indeed, many respondents to this
review suggested that, rather than increasing
safety, elements of the current environment
were detrimental because of the focus on
form-filling and administration – a ‘box-ticking’
approach – rather than engaging with patient
and public safety issues.
The complexity of the current regulatory
and governance environment has developed
cumulatively. New regulatory requirements
and checks have been introduced over time to
improve on previous arrangements, in response
to individual cases of actual and alleged clinical
malpractice, or as a consequence of legislation.
Each new requirement was well-intended but
the combined effect has been the layering of
new bodies or checks onto existing functions.
A key aim of this report is to consider the
regulation and governance pathway as a whole
and its net impact on patients, the public and
UK health research.
This chapter outlines a vision for regulation and
governance that identifies four principles to be
used as a benchmark against which to assess
the current regulatory framework and to test
our proposals for change.
2.2 Our vision for regulation and
governance
Other bodies have developed broad principles
to underpin regulation. In the UK the Hampton
Principles, and those developed by the Better
Regulation Executive, are particularly relevant
to the Academy’s review and focus on ensuring
that regulation and its implementation is more
risk-based.35,36 However, respondents to the
calls for evidence, and participants in the
Patient and Public Involvement (PPI) workshop,
were provided with an opportunity to consider
their own priorities in the context of the UK
environment for health research.
Based on the responses received we have
developed a vision that incorporates the
traditional functions of a regulator (in setting,
monitoring and enforcing standards) with
a desire to improve the regulatory and
governance environment for patients and
researchers (e.g. by providing clear and
consistent guidance). This ideal system would
achieve the following:
• Protect participants’ safety and promote
high-quality health research.
• Apply regulatory and governance
requirements in a way that is proportionate
to the potential benefits and harms of the
research.
• Raise research standards with an emphasis
on promoting compliance rather than
simply policing non-compliance.
• Outline clearly the roles and responsibilities
of the various stakeholders.
• Have the authority and expertise to provide
patients, clinicians, researchers and the
public with clear guidance and advice.
• Be consistent (including across the UK),
transparent and accountable.
37 For further information see
http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/gynaecologicalcancer/gcrc/ukctocs

2020
• Be independent of Government.
• Provide a single point of entry and exit for
research applications and enable all checks
and approvals to be undertaken without
duplication or causing unnecessary delay.
• Facilitate and encourage public and patient
participation in research.
• Engender trust among all stakeholders
including the public, the professions,
healthcare providers and administrators.
• Enhance the UK’s viability and
attractiveness as a site for clinical trials,
experimental medicine and epidemiological
studies through ambitious and
internationally competitive time-frames
by which all regulatory and governance
assessments must be completed.
The desire for a regulation and governance
pathway that is proportionate to the risks and
benefits of research was emphasised in many of
the written submissions (Box 2.1). Respondents
heavily criticised the largely one-size-fits-all’
approach of the current system, which can
distract attention from the most hazardous
research and inhibit valuable, lower risk,
research that could lead to better and safer
interventions.
2.3 Principles
Our principles are intended to provide a
benchmark by which to evaluate the current
regulatory pathway and to reflect our vision
when proposing changes to it. The principles
should be considered together and a balance
needs to be achieved to ensure they are met as
fully as possible. There needs to be clarity and
transparency on how this balance is met.
Principle 1: safeguard the well-being of
research participants
This is the most important principle and deals
directly with individual involvement in research.
It enshrines the need to safeguard the well-
being of research participants. The need to
protect physical well-being is at the core of this
principle, but it also recognises the need to
safeguard the use of an individual’s data
or tissue.
Clearly, there are very different issues to
be considered when assessing the physical
well-being of individuals participating in, for
example, a trial of a new drug compared
with the use of anonymised patient data in
an epidemiological study. A regulation and
Box 2.1 A proportionate approach to regulation and governance
Health research provides benefits for patients and the public, but is also associated with potential
risks. For some studies there may be a possible direct risk to a participant’s physical safety. At
other times, when research involves accessing an individual’s personal data, additional care may
be needed to uphold an individual’s entitlement for confidentiality and, usually, the requirement
for consent. It is important to recognise that there are also risks to the public associated with not
undertaking research. Reliable evidence is needed to assess potential new treatments before they
are used and to evaluate the most effective and safe application of interventions already in use.
In turn, the potential benefits of research will also vary and although a favourable benefit-harm
balance is fundamental, the acceptable balance between benefits and risks varies. For example,
a healthy individual would expect there to be minimal harm from volunteering to help study a
new diagnostic test. In contrast, a patient with a life-threatening disease may be willing to accept
some uncertainty to take part in a higher risk, first-in-man trial of a potential new medicine. It
is important that the regulation and governance pathway recognises these differences and that,
rather than focus simply on process, it is proportionate.

21
governance framework needs to be flexible
enough to ensure that appropriate safeguards
are in place across the spectrum of
research studies.
Informed patient consent is essential to ensure
that this principle can be met and should be a
key component of a regulation and governance
pathway - a point that was emphasised at the
PPI workshop. In some circumstances, seeking
consent is not possible or required (see Chapter
6) and in such circumstances there is a need
to communicate to patients and the public the
safeguards that are in place.
Principle 2: facilitate high-quality health
research to the public benefit
This principle seeks to ensure that research
is undertaken to the benefit of the public and
wider society and recognises the harms caused
by inappropriately prohibiting or delaying
research. The regulation and governance
system not only has a key role in protecting
individuals participating in research but also
in ensuring that they have the opportunity
to gain advantage from innovative medical
advances. Regulators must be accountable and
ensure that they do not unnecessarily obstruct
research. The regulatory system should ensure
high-quality and reliable data are produced,
captured and published – and that poor quality
or fraudulent research is identified.
It is in the public’s interest to have
opportunities to take part in research if they
wish to do so. The regulation and governance
framework should support NHS organisations
in offering all individuals the opportunity to
become involved, if they are eligible, in a
research study.
As discussed in Chapter 1, health research
in the UK provides considerable economic
benefits. For these to continue, the regulatory
and governance environment must not create
unnecessary barriers and should support and
maintain a vibrant life sciences industry.
Principle 3: be proportionate, efficient and
coordinated
The individual components of the regulation
and governance pathway need to work in an
integrated manner. The various checks and
assessments need to be coordinated, with
unnecessary and duplicated checks removed.
The system should be cost-effective and
continually improved through self-assessment,
formal review, feedback, and opportunities to
appeal decisions. The regulatory environment
should be efficient and deal with the risks and
benefits of research in a proportionate manner
(see Box 2.1), i.e. characteristics that foster a
system that can support and meet Principles
1 and 2.
Principle 4: maintain and build confidence
in the conduct and value of health research
through independence, transparency,
accountability and consistency
This principle focuses on the importance of
building confidence and trust in the conduct
and value of research among patients, and
the public, as well as across the NHS, industry
and research community. The independence
of regulatory bodies from Government is
considered fundamental to meeting this
principle, but all stakeholders involved in
research have an important role to play.

2222

23
3 Culture around health research
3.1 Introduction
As described in Chapter 1, health research
involves a diverse range of stakeholders. They
include the healthcare professions, patients
and the public, non-commercial organisations
such as the National Institute for Health
Research (NIHR) and the Medical Research
Council (MRC) and health research charities
such as Cancer Research UK and the Wellcome
Trust. Universities, commercial organisations
and the — as well as the various regulatory
and governance agencies – are also critical
elements of the research environment.
In this report we use the term ‘culture’ to refer
collectively to the understanding, attitudes
and behaviours that stakeholders demonstrate
towards health research. The culture of these
stakeholders — and their mutual interactions —
is an important factor in the amount of research
undertaken, and the efficiency and application
of the regulation and governance pathway.
Submissions to this review indicated a general
perception that cultural barriers need to be
broken down if the UK is to realise its research
potential. Regulatory and governance bodies
such as the National Research Ethics Service
(NRES) and the Medicines and Healthcare
products Regulatory Agency (MHRA) clearly
play a leading role in setting the tone. The
current approach taken by these bodies is
described in later chapters. This chapter
focuses on culture with regard to three groups:
patients and the public, the NHS, and the
research community.
3.2 Patients and the public
Patients and the public are essential partners
in health research. In some cases it can be
difficult to distinguish between ‘patients’ and
‘the public’. The comprehensive nature of the
NHS means that most of the public can be
considered patients because they are registered
(and have records stored) with their GPs. This
was described by one contributor to the review
who simply referred to ‘patients’ and ‘potential
patients’. Patient groups play an increasingly
significant role in research, particularly by
increasing the recruitment of patients into
clinical trials. Yet attendees at Patient and
Public Involvement (PPI) workshop felt that
such groups were still under used by other
stakeholders in the research environment.
3.2.1 Support for health research
At the broadest level, patients and the public
have a vested interest in research. They
contribute to its funding through taxes and by
donations to health research charities. They
also benefit from the advances of research
and new knowledge and treatments it can
generate. Although it is difficult to capture
and communicate the range of public views
on research, in general there is strong public
support for health research in the UK:
• Large numbers of participants have been
recruited to clinical trials and population
studies. For example, the UK Collaborative
Trial of Ovarian Cancer Screening37 and
UK Biobank38 have recruited their targets
of 200,000 and 500,000 individuals
(respectively) with minimal objection to the
use of their healthcare data.
• The attitudes of over 1,000 adults towards
participating in health research were
examined in the Wellcome Trust Monitor
survey.39 71% of participants indicated that
they would be willing to give blood or tissue
samples for research and 62% were willing
to test a new treatment for a disease from
which they were suffering.
• Public engagement initiatives in relation to
specific issues, such as the use of patient
data, generally show that research is
warmly supported (see Box 6.6).
38 For further information see http://www.ukbiobank.ac.uk/
39 Butt S, et al. (2009). Wellcome Trust Monitor: survey report.
http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_grants/documents/web_document/wtx058862.pdf

2424
However, such support is not unconditional
and public confidence could be damaged by
actions that are perceived to be an abuse of the
system. An effective regulation and governance
system has an important role in building and
maintaining public trust and securing a ‘social
licence’ for health research.40
3.2.2 Engagement with health research and
its regulation
The general view of respondents and
participants at the PPI workshop – and a
view shared by the Academy — was that it is
essential patients and the public:
• Understand the role and importance of
research as an integral part of the care
system.
• Inform the priorities, design, and
implementation of research and the
regulation pathway.
Respondents to our review considered it
important that patients appreciate that
high-quality clinical service in the NHS is
underpinned by research – and that this
research relies on the participation of patients,
as well as access to their tissues and data.
PPI workshop participants highlighted the
importance of public communication about
different types of health research.
In general, there was a consensus that a
more sophisticated dialogue with the public is
needed, where the ‘rights’ of patients to the
best healthcare are discussed in the context of
their ‘responsibilities’ towards improving the
evidence upon which that healthcare is based.
Establishing such a dialogue would enable
the public to become genuine partners in the
research process. It is our view that the public
should be encouraged to consider the impact
that their involvement in research could have
on them as individuals, and on society as a
whole. Organisations such as INVOLVE and
the Association of Medical Research Charities
(AMRC) have key roles to play in providing
coordinated information for patients and
the public on the role and benefits of health
research (see Recommendation 1).
To be effective, regulation and governance
should be informed by public views. Several
of the responses highlighted areas where the
current regulation and governance does not
accurately represent majority opinion. For
example, the Royal College of Pathologists’
Lay Committee and attendees at the PPI
workshop both considered the regulation
around the use of tissue from living subjects to
be disproportionate in relation to most patients’
concerns (see Chapter 7). Attendees at the
workshop felt that patients should routinely
be offered the option that tissue excess to
diagnostic requirements could be used for
research.
There are a large number of organisations
working to improve patient and public
engagement with health research, including
(but not limited to) UK Clinical Research
Collaboration (UKCRC), INVOLVE, regulators
themselves, the medical Royal Colleges,
research charities and disease specific patient
groups. However, there are other opportunities
to increase patient and public involvement
in regulatory and governance processes (see
Chapter 9). Attendees at the PPI workshop
emphasised the following:
• Patients should expect research to be an
integral component of the NHS.
• Generating a national ambition and
appetite for research should be seen as a
responsibility of both the NHS, those who
work in it, and patients.
• Patients should be seen as partners in the
shaping, conduct and scrutiny of health
research activity, as well as in its regulation
and governance.
• Good communications and professional
attitudes are fundamental to creating the
right culture for research including issues
around consent.
• Regulation and governance should support
and remove barriers to – not hinder —
patient participation and involvement in
health research.
40 Dixon-Woods M Ashcroft R (2008). Regulation and the social licence for medical research. Medicine, Health Care and Philosophy 11,
381-391.

25
• Public involvement in the regulation and
governance of research must be robust,
well-informed and properly resourced.
• Any move towards the creation of a single
research regulator (see Chapter 9) should
not be at the cost of losing expertise and
experience within the existing regulatory
system.
3.3 The NHS
Two groups of NHS staff play key roles in health
research and its regulation:
• Healthcare professionals, who undertake
many elements of health research (including
patient recruitment, administering
interventions, and collecting data).
• NHS Trust management, who provide
oversight of research by granting
permission for clinical studies that are
sponsored, or hosted, by the Trust.
3.3.1 Embedding research as a core NHS
activity
The Academy has long championed the
opportunities for UK research available through
the NHS, and we welcome steps taken to embed
research as core NHS activity (Box 3.1). The
White Paper on the NHS in England, ‘Equity and
Excellence: Liberating the NHS’, states that ‘the
Government is committed to the promotion and
conduct of research as a core NHS role’ and the
2011/12 NHS Operating Framework highlights
that ‘continued research and the use of research
evidence in design and delivery of services is
key to achieving improvements in outcomes’.
41,42 These reiterate the messages in the NHS
constitution that ‘Research is a core part of the
NHS. Research enables the NHS to improve
the current and future health of the people it
serves. The NHS will do all it can to ensure that
patients, from every part of England, are made
aware of research that is of particular relevance
to them. The NHS is therefore putting in place
procedures to ensure that patients are notified
of opportunities to join in relevant ethically
approved research and will be free to choose
whether they wish to do so.’ 43
Mechanisms have been put in place in an
attempt to implement these aspirations. For
example, the NHS Operating Framework for
2009/2010 contained a target to double the
number of patients involved in clinical trials.
We are disappointed that this target is not
included in more recent versions of the
Framework, although since 2010 Trusts must
include figures on patient recruitment as part
of their Quality Accounts.44,45 Trusts have also
been encouraged to set goals for research in
their organisation and to publish the average
time it takes for the local research approval
process to be completed.46
It was clear from the PPI workshop that
patients and their representatives see research
as an integral part of the NHS, and some went
so far as to suggest that the NHS should be
renamed the ‘National Health and Research
Service’. It will be vital to seize opportunities
to enhance the culture of research among
forthcoming changes to the structure of the
healthcare system.
41 Department of Health (2010). Liberating the NHS: legislative framework and next steps
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122707.pdf
42 Department of Health (2010). The operating framework for the NHS in England 2011/12.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_122736.pdf
43 Department of Health for England (2009). The handbook to the NHS Constitution.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/@sta/@perf/documents/digitalasset/dh_109785.pdf
44 Department of Health (2008). The NHS in England: the operating framework for 2009/10.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_091445
45 Department of Health (2010). The operating framework for the NHS in England 2010/11.
http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/links/operatingframework2010-2011.pdf
46 Department of Health (2009). Requirements to support research in the NHS.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_102098.pdf

2626
47 Academy of Medical Sciences (2003). Strengthening clinical research. http://www.acmedsci.ac.uk/download.php?file=/images/publication/
pscr.pdf
48 For further information see http://www.nihr.ac.uk/
49 Cameron D, et al. (2010). Four-fold increase in recruitment of cancer patients to NCRN portfolio studies between 2001 and 2010: a tale of
investment bringing returns. Presentation at NCRI Cancer Conference, 7-10 November 2010.
http://www.ncri.org.uk/ncriconference/2010abstracts/abstracts/PP39.htm
Box 3.1 The National Institute for Health Research: strengthening clinical
research.
Since the publication of the Academy report ‘Strengthening Clinical Research’, in 2003, several
important initiatives have been implemented.47 The most significant has been the creation of
the National Institute for Health Research (NIHR).48 The NIHR aims to create a coherent ‘health
research system’ by coordinating and funding research in the NHS in England.
The working group welcomes the considerable achievements of the NIHR in improving the clinical
research environment in England. For example, the Clinical Research Networks have improved
the conduct and delivery of research within specialties and increased participant recruitment
levels. Recent data show that the National Cancer Research Network has contributed to a
situation whereby one in every six cancer patients is involved in research.49 This is the highest
level in the world. We also welcome the parallel efforts of the devolved nations as well as the
many instances of collaborative working across all four nations to facilitate UK wide studies.
There are some important examples of what
can be achieved when the right framework
and culture are put in place. The Northwest
Exemplar (Box 4.1) is a programme that
aims to demonstrate the improved clinical
trial performance that is possible when the
NIHR Clinical Research Network (CRN) works
closely with partners in the pharmaceutical and
biotechnology industries and across the NHS.
Emerging findings from this initiative have
indicated that the involvement of Trust Chief
Executives, Industry Medical Directors and
Network Clinical Directors has been the key to
the initiative’s success.
3.3.2 Research culture among NHS staff
Despite the recent efforts outlined above,
respondents to our review raised serious
concerns about the approach to research
among many NHS healthcare professionals,
managers and administrative staff.
Communicating the value of research
Some responses indicated that healthcare
professionals fail to understand the process of
health research, its potential value, and the
safeguards in place to protect patients. This
can hinder and restrict patient recruitment.
Specifically, the National Cancer Research
Institute (NCRI) Consumer Liaison Group was
concerned that healthcare professionals can be
‘paternalistic’, too protective of patients, and
potentially prevent them from participating in
research studies. Such an approach conflicts
with our Principles 1 and 2. It was perceived
that healthcare professionals also lack the time
and incentives to become involved in research.
This was a source of considerable frustration
to PPI workshop participants, summed up
in the following remarks: ‘We do research
because that’s how you get better treatment.
I’d like to see that carved in stone above every
hospital door’; ‘Research needs to be a core
part of the NHS and a routine part of any first
appointment letter – the NHS approach should
be anticipatory that patients will want to take
part in research’.
There was a strong view expressed to the
working group that the cultural disconnect with
research is particularly prevalent in general
practice and primary care. These settings could
provide considerably greater opportunities for
the engagement of a wider proportion of the

27
population in health research. The opportunities
and challenges of research in general practice
were discussed at an Academy workshop held
in 2008.50
Embedding research in NHS processes
It was clear from the call for evidence that
respondents believe that a cultural step change
is needed before research is treated as a core
NHS activity throughout the UK. We hope that
communicating the role of health research in
the delivery and improvement of NHS care to
healthcare and management staff at all levels
in the NHS will go some way to address this
(Recommendation 1). However, this needs
to be complemented by steps to formally
and irreversibly embed health research into
NHS leadership and governance processes
(Recommendation 2).
Respondents particularly emphasised the need
for a change in the attitude and behaviour
of NHS managers. Some perceived health
research to conflict with managerial goals for
service delivery because research requires
key resources including staff time and access
to facilities and equipment. This problem is
compounded by the tensions between short-
term NHS targets and the longer-term nature
of research and its impact on clinical practice.
Although clinical services are clearly a priority,
it is important that NHS managers recognise
that research is an essential component of good
clinical services.
Recommendation 2 outlines several initiatives
aimed at embedding research as a core
function of the NHS. These include the need
to address the current cultural and practical
barriers around the provision of excess
treatment costs (ETCs) (see also section 4.5.4).
Studies attracting ETCs are those most likely
to change clinical practice and should therefore
be supported. However, concerns within Trusts
about recovering ETCs are a major barrier
and a cause of significant delay to some non-
commercial research. In theory, ETCs are
covered by the commissioning budget but the
mechanisms in place for Trusts to claim these
costs are impractical and create a further
disincentive for research. The provision of ETCs
must be streamlined.
In addition to the initiatives outlined in
Recommendation 2, the Academy has
previously recommended that the UK’s Clinical
Excellence and Distinction Awards should be
retained because of their important role in
providing incentives to clinicians to devote
time to research.51 These Awards are currently
under review and we recommend that the UK
Health Departments should use the Awards
to recognise contributions to the operational
effectiveness of clinical studies in addition to
the achievements of research leaders at the
local level.
Cultural change in the NHS needs to be
accompanied by a transformation in the
approach taken to regulatory and governance
checks within individual Trusts. NHS Trusts
and primary healthcare sites have important
responsibilities and liabilities around research
whether they are acting as research sponsors
or hosts. However, the prevailing risk-averse
culture towards research leads to over-
cautious approaches in many NHS Trusts.
This is evidenced in the time taken to approve
individual research studies and the duplication
of minor checks and administrative processes.
Chapter 4 focuses on how the current NHS RD
permissions process, identified in the evidence
as the major bottleneck to health research in
England, must be streamlined.
50 Academy of Medical Sciences (2009). Research in general practice: bringing innovation into patient care.
http://www.acmedsci.ac.uk/download.php?file=/images/publication/12569153801.pdf
51 Academy of Medical Sciences (2010). Response to the consultation for the review of compensation levels, incentives and the Clinical
Excellence and Distinction Award schemes for NHS consultants.
http://www.acmedsci.ac.uk/download.php?file=/images/publication/CEAconsu.pdf

2828
3.4 Researchers
Evidence received by the working group
indicated that researchers themselves can be
responsible for delays to approval processes,
for example, by providing incomplete or
incorrect applications. Indeed, the content
of submissions to this review betrayed a
lack of awareness among some researchers
of the details of the current regulatory and
governance pathway. Issues around the
provision of suitable support for researchers
to navigate the regulation and governance
pathway are considered in other parts of this
report, including Chapters 8 and 9. However,
we strongly emphasise that it is essential for
researchers to take responsibility for producing
a correct and complete research application,
using the guidance and support available to
them.
Previous reports have noted that researchers
are likely to complain about the burden
associated with regulation and governance.52
In some cases this criticism is justified.
For example, respondents highlighted the
unnecessarily demanding requirements
of some regulators including the rejection
of applications due to minor deviations in
document file names, or the need to submit
empty documents (simply to ‘tick a box’) when
the content is irrelevant to a particular study.
Such inappropriate demands are a significant
reason why researchers apparently fail to
provide complete or correct applications.
We also recognise, however, that it is essential
for researchers to understand the generic
benefits that appropriate regulation and
governance brings and the role it plays in
building public confidence in research. They
are sometimes poor at expressing the potential
value and impact of their studies both to
their colleagues and to the wider public. It is
important that researchers take responsibility
for clearly communicating these messages
and to contribute to increased engagement
in research among the public and the NHS.
Research funders and other stakeholders –
particularly the health research charities that
act as a bridge between patients, clinicians and
researchers – have an important role in helping
to communicate the value of research in a
responsible manner.
52 Dixon-Woods M Ashcroft R (2008). Regulation and the social licence for medical research. Medicine, Health Care and Philosophy
11, 381-391.

29
Recommendations
To support recommendations made throughout this report to improve the regulatory and
governance pathway, cultural change is required within the NHS to embed health research as
a core function, to foster a more facilitative approach to research governance and to promote
public and patient engagement in research. All those involved in health research and its
regulation have a role to play in supporting this culture change and in enabling the UK to realise
its potential as a world leader in health research.
Recommendation 1: The UK health departments, with the support of other government
departments, should communicate the core role of health research to all NHS staff, and
continue to work with organisations such as INVOLVE and AMRC to provide coordinated
information for patients and the public about the role and benefits of health research.
Recommendation 2: To embed research as a core function in the NHS we recommend that:
a. The Director General of NHS RD should serve as a member of the proposed NHS
Commissioning Board in England.
b. Key metrics and indicators of research activity should be developed by the proposed new
Health Research Agency (HRA) (Recommendation 13), in consultation with stakeholders,
and included in the next NHS Operating Framework. These metrics should include timelines
for assessment of local feasibility, delivery and recruitment under the new National
Research Governance Service (NRGS) model (Recommendation 3). The use and publication
of these metrics should allow the research performance of Trusts to be compared and
scrutinised by the Trust Board, research funders and the public.
c. An executive director of each NHS Trust should be responsible for promoting research
within the organisation and report on current research activity (including metrics) at each
Board meeting.
d. Challenges around the definition and allocation of research costs remain a major
disincentive for Trusts to engage in research. The forthcoming re-organisation of NHS
commissioning arrangements provides an important opportunity to improve the provision of
Excess Treatment Costs and remove the current difficulties this creates for non-commercial
research.
e. All those involved in training healthcare professionals, including the General Medical
Council, the Nursing and Midwifery Council, the General Pharmaceutical Council, medical
schools and the medical Royal Colleges, should ensure that the NHS workforce is aware of
the important role of health research and equipped to engage with studies taking place in
their Trust. This should include providing support to patients who are considering whether
or not to participate in research.

3030

31
4 NHS research and development
4.1 Introduction
Most UK health research involving patients
is undertaken in the NHS and it is therefore
crucial that the regulatory and governance
processes in the NHS support the Principles
outlined in Chapter 2.
As described in Chapter 3 the NHS is, to a
large extent, still perceived to be a challenging
and inconsistent research partner by both
the academic and commercial research
communities. In recent years, several initiatives
have increased the standing of the NHS as
a health research collaborator. The most
significant improvements have resulted from
the establishment of the NHS National Institute
for Health Research (NIHR) in England (see
Chapters 1 and 3). Significant investment in the
research infrastructure has been complemented
by new systems and processes to improve
the mechanisms in place to assess and
deliver research. Several of these initiatives,
for example the creation of Comprehensive
Local Research Networks (CLRNs)53, and
an Integrated Research Application System
(IRAS)54, are covered elsewhere in this report.
Despite some progress, the research potential
of the NHS is largely unfulfilled. Research
projects are being funded and granted the
necessary ethics and regulatory approvals,
but are then being significantly delayed
or prevented because of the challenges in
obtaining permission from the individual
NHS Trusts involved. There was consensus
in submissions from across all sectors that
the current process of obtaining NHS RD
permission is the most significant barrier to
health research in the UK, particularly for
multisite studies. The process is cumbersome
and bureaucratic with a focus on procedures
rather than outcomes. This chapter describes
the following problems that are endemic in the
current system:
• Duplication and reinterpretation of checks
by NHS Trusts that are the responsibility of
national regulators such as the Medicines
and Healthcare products Regulatory Agency
(MHRS) and National Research Ethics
Service (NRES).
• Inconsistency in the interpretation of
checks, such as requirements to access
patient data, among and within Trusts.
• Replication of study-wide checks by each
individual Trust involved in the study.
• Lengthy negotiation of contracts and
costings by each Trust.
• Lack of oversight of the NHS permission
process and absence of a clear mechanism
for an overall agreement to begin a
multisite study.
The negative impact of this situation is felt
by both commercial and non-commercial
research organisations and across all research
disciplines. There is a clear and obvious need
for a step change in how NHS RD permissions
are granted. In this chapter we propose a new
approach for RD permissions and the creation
of a new National Research Governance Service
for England (NRGS). How this service will
interplay with other aspects of the regulation
pathway for health research is considered in
Chapter 9.
4.2 Undertaking research in the NHS
Individual NHS Trusts vary significantly in their
research activities. Trusts linked to leading
teaching hospitals and universities are likely to
initiate a larger proportion of research studies
than those without such associations. To ensure
that research can deliver benefits and meet
the needs of all UK patients it is crucial that
research takes place efficiently across the entire
health service. This is especially important for
research studies that are limited by the size of
the patient population, e.g. for rare diseases.
It is often the case that studies take place in
53 For further information see http://www.crncc.nihr.ac.uk/
54 For further information see https://www.myresearchproject.org.uk/SignIn.aspx

3232
multiple countries to reach the numbers of
patients required to achieve sufficient power.
It is a significant loss to patients in the UK if,
as suggested by the evidence, studies simply
cannot recruit patients owing to delays in
attaining NHS permission (see section 4.4.1) -
with consequent reputational risk to the NHS as
an effective clinical trial environment.
Each NHS organisation is a separate legal entity
and has a legal duty of care for its patients.
It is the view of NHS Trusts that fundamental
elements of NHS RD permission are not
therefore transferable among NHS sites. This
means that each NHS Trust is required to review
and assess every research application. Before
a Trust will grant RD permission a series of
checks are undertaken. From the perspective
of an individual NHS Trust these checks can be
categorised as addressing one of three issues:
• Is the Trust aware of the potential financial
implications of the research and are
suitable arrangements in place?
• Has the Trust made the necessary
arrangements to support the activity and
are the resources in place?
• Is the Trust aware of the potential impact
of the research in terms of risk and are all
the activities for which they are responsible
compliant with the law?
The evidence submitted to this review
suggests the approach taken by many
NHS Trusts focuses overly on the third
question, contributing to a risk-averse
culture perpetuated by concerns around
indemnity and harm. This mindset is perhaps
understandable given the complexity of the
regulation framework and uncertainty around
the interpretation of certain guidance and
legislation (see section 4.4.3). However, the
approach taken by many Trusts appears to give
priority to safeguarding the organisation over
the potential benefits of research to patients
and the public. This risk-averse approach is
often described in the context of protecting
patients, although there is no evidence that
this attitude, which delays or stops research,
results in greater safety of patients and the
public. The approach neither meets Principle
1 (safeguarding patients) or Principle 2
(promoting research for public benefit).
In practice, the three questions listed above are
currently addressed for each individual research
application at each Trust, by undertaking
checks at the following levels (the examples
provided reflect individual checks that are part
of the current system described in section 4.3):
• Confirmation that external approvals,
licences and authorisation have been
granted. This involves reassessing, for
example, that ethical approval has been
granted (see Chapter 8) or that, where
required, a clinical trial authorisation has
been obtained (see Chapter 5).
• Undertaking a study-wide assessment
of the suitability of the research to be
conducted in the NHS. This looks at issues
that are common across all sites involved
in a study including, for example, is the
researcher (or Chief/Principle Investigator)
leading the study suitably qualified? Is
study sponsorship in place with appropriate
indemnity arrangements? Are the study-
wide pharmacovigilance arrangements
clearly described and appropriate?
• Checking the local arrangements at each
individual Trust involved in a study. Local
checks can be divided into the following:
 An assessment of the local governance
arrangements - for example, are local
pharmacovigilance requirements in
place? Is the research on that site in
accordance with the Data Protection
Act and NHS confidentiality policy? Are
appropriate arrangements in place for
the local research team?
 An assessment of local delivery issues.
This covers questions such as; are the
local resources, equipment and facilities
suitable for the study? Have all the
relevant internal authorisations within
the research site been granted from
pharmacy or radiology departments?

33
There is no central body with responsibility
for overseeing consideration of these issues
and each NHS organisation currently provides
permissions on a site by site basis. In the
absence of top-down guidance as to how checks
should be interpreted, Trusts have evolved
their own processes leading to a diversity of
approaches and a host of inconsistencies. The
following section briefly reviews the current
process before using the evidence, and case
studies received, to describe the challenges
this creates.
4.3 Gaining RD permission: the
current process
Each individual Trust involved in a study
reviews the research and provides local RD
permission. This function is undertaken by
Trust RD offices. The current practices of
RD offices were developed in response to
the Research Governance Framework (RGF)
for Health and Social Care.55 Introduced in
2004, the RGF requires NHS organisations to
undertake a series of checks before granting
local NHS permission. The manner by which
the RGF was introduced, whereby each
organisation implemented the principles at a
practical level on an individual basis, has led to
inconsistencies in the requirements of individual
NHS Trusts (see section 4.4).
Systems currently in place to facilitate and
support the RD permission process do not
remove responsibility from an individual Trust
but attempt to seek approval across all Trusts
involved in a study in a coordinated way. These
processes include:
• Comprehensive Local Research Network
(CLRNs): Each of the 25 CLRNs funds a
research management and governance
workforce whose role is to assist
investigators in obtaining permission
for their studies. The support of CLRNs
and other NIHR initiatives such as the
Coordinated System for NHS Permission
(CSP) are only applicable to NIHR Clinical
Research Network (CRN) Portfolio research.
• NIHR Portfolio: In England, the Department
of Health has determined that studies
(clinical trials and other well designed
studies which involve the NHS) that are
funded by NIHR, other areas of Government,
and specified NIHR non-commercial Partners
are automatically eligible to be included in
the NIHR Portfolio and gain support from
CLRNs.56 In England studies included in the
NIHR Portfolio have access to infrastructure
support and access to training courses on
Good Clinical Practice (GCP).
• NIHR Coordinated System for gaining NHS
Permissions (CSP). For studies on the NIHR
Portfolio this provides coordinated provision
of documents and sets out 37 checks to be
undertaken. It separates CSP checks into:
 Global governance checks, which are
applicable to the study as a whole and
should be undertaken once by a Lead CLRN.
 Local governance checks that recognise
that NHS permission is required at each
site, and are assessed using a Site
Specific Information (SSI) Form.
• NIHR Research Support Services (RSS).
RSS is intended to complement CSP and:
provide NHS Trust RD Departments with
guides to risk management, competencies
and training needs, establish a monitoring
system for collecting and publishing
performance information and agree
delivery timelines for use in the NHS.
It is clear from the evidence that as a result
of these national initiatives, a few Trusts have
developed more efficient local processes to
grant NHS permission in a timely manner
(see Box 4.1).
55 Department of Health (2005). Research governance framework for health and social care: second edition.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
56 For further information see http://www.crncc.nihr.ac.uk/about_us/processes/portfolio

Newpathw

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (20)

Destaque

Destaque (20)

Semelhante a Newpathw

Semelhante a Newpathw (20)

Último

Último (20)

Newpathw